Escitalopram

Product NDC
72189-449
11-digit product format
721890449
Labeler code
72189
Product ID
72189-449_2c4db59b-4a03-c45c-e063-6294a90ab0ff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct_Rx
Application
ANDA078032
Marketing category
ANDA
Marketing start
2023-03-20
Substance
ESCITALOPRAM OXALATE
Active strength
5 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Escitalopram
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESCITALOPRAM OXALATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5U85DBW7LO
Rxcui351249

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
04dce598-23c6-b7e7-c3dd-9b9cfd6e1615Product name620170718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-449-30Escitalopram30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-449ESCITALOPRAM TABLET, FILM COATED [DIRECT_RX]2Current NDC, 1 package rows20250123_f75aabf8-f4a1-acd1-e053-6294a90ab9a6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351249escitalopram oxalate 5 MG Oral TabletPSNf75aabf8-f4a1-acd1-e053-6294a90ab9a62
351249escitalopram 5 MG Oral TabletSCDf75aabf8-f4a1-acd1-e053-6294a90ab9a62
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSYf75aabf8-f4a1-acd1-e053-6294a90ab9a62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72189-449-307218904493030 TABLET, FILM COATED in 1 BOTTLE (72189-449-30) 2023-03-20NoNoCurrent